Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.

Overview

Prospective randomized controlled clinical trials (single arm study) of surgical treatment modalities for supratentorial high grade gliomas within the next two years.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 1, 2021

Detailed Description

Supratentorial high grade gliomas are for surgical resection in any case according to many factors. Investigators will compare the outcomes/survival rate and clinical outcome of the different resection types (Total, near total, subtotal/debulking) of supratentorial high grade gliomas according to the clinical condition and comorbidities of the patient, the location and morphology of the lesion, the grading of lesions, and the clinical experience of the neurosurgeon.

Interventions

  • Procedure: Supratentorial high grade gliomas resection.
    • Total, near total or subtotal/debulking resection of the brain supratentorial high grade gliomas

Clinical Trial Outcome Measures

Primary Measures

  • Clinical picture using Modified Rankin’s Scale (mRS).
    • Time Frame: 1 year
    • The changes in clinical condition of the patients will be assessed using Modified Rankin’s Scale (mRS) before and after treatment. The scale runs from 0-6, running from perfect health without symptoms to death. 0 – No symptoms. – No significant disability. Able to carry out all usual activities, despite some symptoms. – Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. – Moderate disability. Requires some help, but able to walk unassisted. – Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. – Severe disability. Requires constant nursing care and attention, bedridden, incontinent. – Dead.

Secondary Measures

  • Recurrence or increased residual
    • Time Frame: within 3 months after treatment
    • Recurrence of the tumor

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who will undergo surgical excision of the supratentorial high grade gliomas at the time of study (two years). – Denovo disease for the first time. – Any age Exclusion Criteria:

  • Low-grade Gliomas. – Infratentorial high-grade gliomas. – Past history of gliomas. – Patients who are unfit for any neurosurgical interventions. – Patients who do not receive their adjuvant standard therapy.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amr Badary, Resident Doctor – Assiut University
  • Overall Official(s)
    • Mahmoud Ragab, Study Director, Assiut University
  • Overall Contact(s)
    • Amr Badary, 00201023310102, amr.badary@hotmail.com

References

Gulati S, Jakola AS, Nerland US, Weber C, Solheim O. The risk of getting worse: surgically acquired deficits, perioperative complications, and functional outcomes after primary resection of glioblastoma. World Neurosurg. 2011 Dec;76(6):572-9. doi: 10.1016/j.wneu.2011.06.014.

Ostrom QT, Bauchet L, Davis FG, Deltour I, Fisher JL, Langer CE, Pekmezci M, Schwartzbaum JA, Turner MC, Walsh KM, Wrensch MR, Barnholtz-Sloan JS. The epidemiology of glioma in adults: a "state of the science" review. Neuro Oncol. 2014 Jul;16(7):896-913. doi: 10.1093/neuonc/nou087.

Ryken TC, Frankel B, Julien T, Olson JJ. Surgical management of newly diagnosed glioblastoma in adults: role of cytoreductive surgery. J Neurooncol. 2008 Sep;89(3):271-86. doi: 10.1007/s11060-008-9614-5. Epub 2008 Aug 20. No abstract available.

Sanai N, Polley MY, McDermott MW, Parsa AT, Berger MS. An extent of resection threshold for newly diagnosed glioblastomas. J Neurosurg. 2011 Jul;115(1):3-8. doi: 10.3171/2011.2.jns10998. Epub 2011 Mar 18.

Orringer D, Lau D, Khatri S, Zamora-Berridi GJ, Zhang K, Wu C, Chaudhary N, Sagher O. Extent of resection in patients with glioblastoma: limiting factors, perception of resectability, and effect on survival. J Neurosurg. 2012 Nov;117(5):851-9. doi: 10.3171/2012.8.JNS12234. Epub 2012 Sep 14.

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